MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNKNOWN POWER PORT

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.

Event Description

It was reported that approximately six months post a port placement, the catheter was allegedly found to be cracked under imaging and pinched off near subclavian area of the patient over routine movement of the patient.It was further reported that the catheter allegedly had leak.Reportedly, the catheter allegedly kinked in the subclavian area.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port and a catheter was returned for evaluation.In addition to the returned physical sample, one electronic photo and image was provided for review.The photo shows a parallel split on the center portion of the catheter.The image depicts the device introduced via a left subclavian venous access and extravasation of infused contrast is seen from an irregular segment of catheter in the midclavicular region.A complete circumferential break was noted to the proximal end of the catheter returned.Catheter wear was observed throughout the center portion of the catheter.Multiple parallel splits were noted on the catheter border approximately 1.2cm, 2.8cm and 11.7cm from the proximal end of the catheter.Upon infusion, leaks were observed from the parallel splits on the catheter.Aspiration was attempted and was unsuccessful.Therefore the investigation is confirmed for the reported fracture, deformation and fluid leak issue.The definitive root cause for the reported event could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that approximately six months post a port placement, the catheter was allegedly found to be cracked under imaging and pinched off near subclavian area of the patient over routine movement of the patient.It was further reported that the catheter allegedly had leak.Reportedly, the catheter allegedly kinked in the subclavian area.There was no reported patient injury.

• Brand Name: UNKNOWN POWER PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18884383
• MDR Text Key: 337410157
• Report Number: 3006260740-2024-01022
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female